FDA advisers recommend approving anticlotting drug

TRENTON, N.J. 
Outside advisers to the Food and Drug Administration voted Thursday to recommend that the agency approve a new anticlotting drug for use in millions more patients.

Johnson & Johnson and partner Bayer Healthcare of Germany, which jointly developed the drug, Xarelto, are seeking U.S. approval for preventing strokes in patients with a common irregular heart rhythm known as atrial fibrillation. The drug is already approved to prevent clots in people getting knee and hip replacements.

Nine panel members voted to recommend approving Xarelto to prevent strokes in patients with atrial fibrillation. Two members voted against that and one person abstained. The FDA is expected to make a final decision by early November.

The panel's vote came despite a very negative review by FDA staff released two days ago. It stated that the latest study of Xarelto didn't convincingly prove it's as effective and safe as the longtime standard treatment, warfarin, citing questions about potential stroke and bleeding risks. It also questioned the reliability of some of the data.

The vote came near the end of a daylong hearing that covered technical details of the design of and results from a huge study funded by the companies and meant to show Xarelto works better than warfarin.

"We are pleased with the committee's recommendation and look forward to working with the FDA to help make this important therapy available in the U.S.," Dr. Peter DiBattiste, head of J&J's cardiovascular and metabolic research, said in a statement.

Patients and doctors have long wanted a better treatment than inexpensive warfarin because it's difficult to maintain the correct dose in the blood. Too much warfarin can cause dangerous internal bleeding, and too little can result in strokes.

Xarelto, known chemically as rivaroxaban, has been seen as a future blockbuster drug, with eventual peak sales as high as $2.5 billion a year in the U.S. alone - about 70 percent of that depending on use in patients with atrial fibrillation, according to one analyst. About 2.2 million Americans, plus 4.5 million people in the European Union, have the condition.

The advisory panel's vote late Thursday was followed by a discussion of whether the makers should be able to claim Xarelto works better than warfarin, which could give the companies a marketing edge against warfarin and new drugs in the category. The consensus was that the claim should not be allowed, according to an FDA spokeswoman. That could crimp potential sales.

In after-hours trading, J&J shares rose 15 cents to $65.10.

On Tuesday, a 388-page report by FDA staff reviewers recommended against approving Xarelto for patients with atrial fibrillation, in which the heart's upper chambers quiver ineffectively - temporarily or for years. That reduces blood flow through the heart, raising the risk of dangerous blood clots forming and triggering a stroke.

The FDA staff reviewers wrote that results of a late-stage study of more than 14,000 patients, known by the acronym ROCKET, don't make clear how safe Xarelto is, or whether it's as effective as the widely used drug warfarin. They stated that an additional study of Xarelto is needed.

During Thursday's meeting before the FDA's Cardiovascular and Renal Drugs Advisory Committee, Johnson & Johnson officials argued their data show Xarelto is safe and effective.

Bayer Healthcare already markets rivaroxaban in 110 countries around the world. Johnson & Johnson has the U.S. marketing rights.

Xarelto, a daily pill, works by blocking a clotting protein. Older blood thinners, including warfarin, work by preventing platelets from sticking together.

Patients taking warfarin, sold as Coumadin and other brands, need frequent blood tests to ensure they're getting the right dose.

That's made an easier-to-use alternative a key goal of several drugmakers. Last October, the FDA approved the first warfarin alternative for atrial fibrillation - Pradaxa, known chemically as dabigatran, made by the German company Boehringer Ingelheim.

Another new drug, Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc., was approved in the 27 European Union countries on May 20. The companies plan to seek U.S. approval later this year.

Credit Suisse analyst Catherine Arnold wrote this week that she continues to expect Eliquis to dominate the category, with two-thirds of market share by 2020.